BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 14982406 · Received July 11, 2022

    Report

    Report Number
    1319808-2022-00013
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    March 26, 2022
    Report Date
    July 11, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT LOWER AND HIGHER THAN EXPECTED VITROS VALPROIC ACID (VALP) RESULTS WERE PREDICTED FROM MULTIPLE LEVELS OF NON-VITROS MAS OMNI-CORE CONTROL LOT 2406 USING TWO DIFFERENT VITROS VALP REAGENT LOTS ON TWO DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. J76000731. VITROS VALP REAGENT LOT 2511-30-8922. VITROS VALP REAGENT LOT 2511-31-9364. THE MOST LIKELY ASSIGNABLE CAUSE IS UNKNOWN; HOWEVER, INCONSISTENT PRE-ANALYTICAL SAMPLE HANDLING CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. J76000726. VITROS VALP REAGENT LOT 2511-31-9364. THE MOST LIKELY ASSIGNABLE CAUSE A SUBOPTIMAL CALIBRATION EVENT. THE RESULTS THAT MET POTENTIAL HEALTH AND SAFETY CRITERIA WERE ALL ASSOCIATED WITH A CALIBRATION EVENT PERFORMED ON (B)(6) 2022. THE HIGHER THAN EXPECTED VITROS VALP RESULTS USING REAGENT LOT 2511-31-9364 ON J76000726 APPEAR TO BE ASSOCIATED WITH THE (B)(6) 2022 CALIBRATION, EVEN THOUGH THE CALIBRATION RESPONSES AND PARAMETERS LOOK TYPICAL. THE CAUSE OF THE ATYPICAL CALIBRATION IS UNKNOWN. ACCEPTABLE VITROS VALP RESULTS WERE OBTAINED USING CALIBRATIONS PERFORMED ON (B)(6) 2022 AND (B)(6) 2022. A REVIEW OF THE AFFECTED VITROS VALP RESULTS OBTAINED ON BOTH VITROS J76000731 AND J76000726 DETERMINED THE VITROS VALP REAGENT PACKS IN USE WHEN THE AFFECTED RESULTS WERE OBTAINED ALSO GENERATED ACCEPTABLE RESULTS AFTER THE EVENTS OCCURRED. THIS INDICATES THE VITROS VALP REAGENT PACKS IN USE DID NOT LIKELY CONTRIBUTE TO THE EVENT. THERE WAS NO INDICATION THE VITROS XT7600 INTEGRATED SYSTEMS MALFUNCTIONED, AND IT IS UNLIKELY THAT BOTH INSTRUMENTS WERE NOT PERFORMING AS INTENDED. HOWEVER, SINCE DIAGNOSTIC VITROS GENT WITHIN-RUN PRECISION TESTING (USED TO ASSESS ANALYZER PERFORMANCE) WAS NOT PERFORMED AS REQUESTED, AN INSTRUMENT RELATED PERFORMANCE ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT. EMAIL ADDRESS FOR CONTACT OFFICE ABOVE IS (B)(6).

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED THAT LOWER AND HIGHER THAN EXPECTED VITROS VALPROIC ACID (VALP) RESULTS WERE PREDICTED FROM MULTIPLE LEVELS OF NON-VITROS MAS OMNI-CORE CONTROL LOT 2406 USING TWO DIFFERENT VITROS VALP REAGENT LOTS ON TWO DIFFERENT VITROS XT7600 INTEGRATED SYSTEMS. J76000731. VITROS VALP REAGENT LOT 2511-30-8922. MAS L1 VALP RESULTS OF 10.7 AND <10.0 UG/ML VS. THE EXPECTED RESULT OF 23.8 UG/ML. MAS L2 VALP RESULTS OF 89.4, 60.2, 63.6, 64.4, 55.3, 47.8 AND 44.7 UG/ML VS. THE EXPECTED RESULT OF 71.7 UG/ML. MAS L3 VALP RESULTS OF 91.1, 96.8, 97.4, 95.1, 89.9, 83.0, 89.2, 92.6 AND 91.7 UG/ML VS. THE EXPECTED RESULT OF 127.5 UG/ML. VITROS VALP REAGENT LOT 2511-31-9364. MAS L2 VALP RESULT OF 56.3 UG/ML VS. THE EXPECTED RESULT OF 71.7 UG/ML. MAS L3 VALP RESULTS OF 90.8 AND 96.0 UG/ML VS. THE EXPECTED RESULT OF 127.5 UG/ML. J76000726 VITROS VALP REAGENT LOT 2511-31-9364 MAS L1 VALP RESULTS OF 35.8, 35.1, 34.8, 36.0, 34.9, 34.3, 36.8, 37.0, 34.8, 34.5, 34.2, 33.9, 34.8, 34.8 AND 34.8 UG/ML VS. THE EXPECTED RESULT OF 23.8 UG/ML MAS L2 VALP RESULTS OF 88.4, 91.8 AND 86.7 UG/ML VS. THE EXPECTED RESULT OF 71.7 UG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THERE WAS NO REPORT OF AFFECTED PATIENT RESULTS. THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT IS NUMBER SEVEN OF TEN MDR¿S FOR THIS EVENT. TEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TEN DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS 2445776, 2445803, 2449695 AND IVD 509091.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913314 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS 2511-30-8922

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown